Purpose.This FOA issued by the National
Institute on Aging (NIA), National Institutes of Health, supports new and
renewal applications for Claude D. Pepper Older Americans Independence Centers
(OAICs) (centers of excellence in geriatrics research and training).

Mechanism of Support. This FOA will utilize the P30 Center Core Grant mechanism.

Funds Available and Anticipated Number
of Awards.The total amount to be awarded is approximately $3.3
million for three new or renewal awards in FY2011, and $1.1 million for one new
or renewal award in FY2012.

Budget
and Project Period.The total project period for an application submitted in
response to this funding opportunity is five years. Direct costs are limited to
$800,000 per year for a five-year period.

Application Research Strategy Length: The
P30 Research Strategy section may not exceed 6 pages, including tables,
graphs, figures, diagrams, and charts. See Table of Page
Limits.

Eligible Project
Directors/Principal Investigators (PDs/PIs). Individuals
with the skills, knowledge, and resources necessary to carry out the
proposed research are invited to work with their institution/organization
to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for NIH support.

Number
of PDs/PIs.Multiple PD/PI’s are not permitted.

Number of Applications.Each applicant organization
may submit one application.

Resubmissions. Applicants may submit a resubmission
application, but such application must include an Introduction addressing
the previous peer review critique (Summary Statement). See new NIH policy
on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). See Section IV. 6.
“RESUBMISSION” for more details.

The Claude D. Pepper Older American
Independence Centers (OAIC) program was established in honor of the late
Representative to establish “centers of excellence” in research and
training that will increase scientific knowledge leading to better ways to
maintain or restore independence in older persons.

The OAIC awards are designed to develop or strengthen awardee
institutions’ programs that focus and sustain progress on a key area in
aging research. Each area of focus is one in which progress could contribute to
greater independence for older persons and offer opportunities for training and
career development in aging research. NIA's expectation is that an OAIC, in a
given area of focus, will:

Provide intellectual leadership and innovation;

Stimulate translation between basic and clinical
research, e.g., research to develop or test interventions or diagnostic
tests based on new findings from basic aging research or other basic
research, or studies to improve understanding of mechanisms contributing
to clinical or functional findings;

Facilitate and develop novel multidisciplinary and
interdisciplinary research strategies;

Stimulate incorporation of emerging technologies,
methods and scientific advances into research designs as appropriate;

Serve as a source of advice and collaboration to
other institutions regarding technology, methodology, analysis, or other
expertise; and

Provide career development for future research
leaders.

Area of Focus

To achieve the objectives listed above, each OAIC should promote a
sustained research program in an area of focus through which the center will
accomplish the innovation, leadership, collaborative, and career development
functions described above. It is crucial to the design of an OAIC to
identify one or more important research areas to be addressed, to specify the
goals to be achieved within the five-year OAIC award period, and to provide a
plan to reach these goals and a method to evaluate progress toward these goals
during the course of the OAIC award. The selection of Core activities (see
below) should follow from these considerations.

An OAIC may select an area of research focus from a broad range of topics,
including but not limited to:

Aging–related issues concerning a specific
condition contributing to loss of independence in older persons, e.g.,
role of aging changes in the etiology of the condition, special issues in
the diagnosis, treatment or prevention of the condition in old age;
complications, disability, or symptoms from the condition found
principally in older persons.

Interactions of multiple diseases, disabilities, and
interventions (e.g., medications) in older persons, and their relationship
to risk of morbidity, progression of disability, and efficacy of
prevention or treatment strategies.

An OAIC may define its selected area of focus. In general, each research
focus described above has the need (and/or the potential) for a wide range of
developmental and infrastructural activities that are likely to be
interdependent and synergistic. Thus an OAIC strategy of selecting several key activities
that address its area of focus may have unique benefits.

Since the level of funding for individual OAICs is unlikely to allow
such a set of activities for more than one focus area, applicants are strongly
encouraged to select an area in which their strengths allow their OAIC to
fulfill NIA's goal for the OAIC program and to direct their proposed OAIC
activities toward that research area. The total impact of an OAIC's activities
on progress in the selected field(s) should be a major criterion in selection
of the focus area and will be a major criterion in peer review and program
evaluation.

To capitalize on important new research opportunities or to address
unexpected needs for career development support within their institutions,
OAICs may also support a limited amount of activity in their cores on topics
other than those in their area(s) of focus (see below). Applicants who
anticipate providing such support should propose a system for identifying these
opportunities and needs and for selecting core activities to address them.

Cognition and Behavioral Science Research as an Area of Focus: An
OAIC application should not include major foci on cognition or behavioral and
social sciences, as these are more appropriate for other NIA programs that also
use the Center mechanism. However, OAICs are encouraged to support a
multidisciplinary approach that includes research in these areas as they relate
to the theme or focus of the OIAC.

Health Services Research as an Area of Focus: Research to determine effects
of health practices or services, or the use of new or different types of health
care providers or interventions, is generally appropriate for a Pepper Center
component if the services or interventions follow a defined algorithm and are
delivered to or directly involve the individual patient. Additional
information about NIA’s policy on health services research within the
OAICs can be found on the NIA website (see http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/GeriatricsAndClinicalGerontology/PepperPolicy.htm ).

The
estimated amount of funds available to be awarded as a result of this
announcement is approximately $3.3 million in
fiscal year 2011 for support of three new or renewalCenters and
$1.1 million in fiscal year 2012 for support of one new or renewal Center. The
maximum allowable direct cost that may be requested is $800,000 per year. An
applicant may request a project period of up to 5 years. Future year amounts will depend on annual appropriations.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Although the financial plans of NIA provide support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.

Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.

NIH
grants policies as described in the NIH Grants Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following
organizations/institutions are eligible to apply:

Public/State
Controlled Institutions of Higher Education

Private
Institutions of Higher Education

Hispanic-serving
Institutions

Historically
Black Colleges and Universities (HBCUs)

Tribally
Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

For-Profit
Organizations (Other than Small Businesses)

State
Governments

Indian/Native
American Tribal Governments (Federally Recognized)

Other(s):

Eligible
Agencies of the Federal Government

1.B.
Eligible Individuals

Any
individualwith the skills, knowledge, and resources necessary to
carry out the proposed research as the PD/PI is invited to work with his/her
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH program support.

Number of
Applications.Each applicant organization may submit one application.

Resubmissions.Applicants may submit a
resubmission application, but such application must include an Introduction
addressing the previous peer review critique (Summary Statement). Beginning
with applications intended for the January 25, 2009 official submission due
date, all original new applications (i.e., never submitted) and competing
renewal applications are permitted only a single amendment (A1). See new
NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016).

Applications
must have a D&B Data Universal Numbering System (DUNS) number as the
universal identifier when applying for Federal grants or cooperative
agreements. The D&B number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dnb.com/us/. The D&B number should
be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.

3.
Submission Dates and Times

Applications must be
received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research

Name, address, and telephone number of
the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding
opportunity

Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.

Applications must be
prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, and three signed photocopies in one package to:

Applications must be received on or before the
application receipt date described above (Section IV.3.A.). If an application is
received after that date, the application may be delayed in the review process
or not reviewed. Upon receipt, applications will be evaluated for
completeness by the CSR and for responsiveness by the reviewing Institute.
Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding opportunity
must not include an Introduction describing the changes and improvements made,
and the text must not be marked to indicate the changes from the previous
unfunded version of the application.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at NIH Grants Policy
Statement.

Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence
of pre-award costs in anticipation of a competing or non-competing award
imposes no obligation on NIH either to make the award or to increase the amount
of the approved budget if an award is made for less than the amount anticipated
and is inadequate to cover the pre-award costs incurred. NIH expects the
grantee to be fully aware that pre-award costs result in borrowing against
future support and that such borrowing must not impair the grantee's ability to
accomplish the project objectives in the approved time frame or in any way
adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

PHS398 Research Plan Sections

All
application instructions outlined in the PHS398 Application Instructions are to
be followed, with the following additional requirements below.

Summary
of the OAIC

Introduction
(required for a resubmission or revision application) is limited to 1 page.

A. Face Page. Use PHS 398 Form Page 1. For Item 2, check YES and cite
the OAIC FOA number and title.

B. Project Summary, Relevance,
Project/Performance Sites, Senior/Key Personnel, and Other Significant
Contributors, and Human Embryonic Stem Cells. Use PHS 398 Form Page 2 and 2-continued.The
Project Summary serves as a brief overview of the entire application and
summarizes the general plan and goals for the proposed OAIC. The listing of project/performance
sites should include the applicant institution and all other institutions
collaborating via consortium or contractual arrangements.

C. Table of Contents. Applicants are discouraged from using PHS 398 Form Page
3, as this is intended for single projects. Instead, due to the complexity of
OAIC applications, applicants are strongly encouraged to use the recommended
format provided on the NIA website and to number
all pages consecutively.

D. Budget. Use PHS 398 Form Page 4 and Form Page 5 to provide budget
information listed in the recommended Table of Contents.To aid in
the review of the application, insert consolidated budget tables (Table IA for
the first year and Table IB for the entire project period – see recommended
formats on the NIA website). Place detailed
budgets for individual Cores with the corresponding Cores sections, as in the
recommended format for the "Table of Contents." Justify all
items carefully according to PHS 398 instructions.

For Consortium/Contractual Arrangements, include the
following additional budget information:

A separate detailed budget for the initial
and future years for each institution and, where appropriate, for each unit of
activity at each institution. Request F&A costs for the consortium
institution as a direct cost and include them in the "Other"
category. Insert the amounts requested in the appropriate budgets for the
applicant institution. The detailed consortium/contract budgets follow those
for the appropriate applicant institution budgets.

A composite budget for all units of activity
at each institution for each year, as described in the preceding bullet, as
well as a composite budget for the total proposed funding for each year. Insert
these budget pages after the composite budgets for the applicant institution.

E. Biographical Sketches. NIA staff
will use the information in the biosketch to identify all personnel involved in
the proposed OAIC and their institutional appointments. (That information is
necessary to identify which possible reviewers may be in conflict with the
application.) Also reviewers will use the biosketch to assess the
qualifications of key personnel for their roles in the proposed OAIC (the
“Investigators” criterion in the central review criteria). These
two functions determine how the biosketches should be presented in the
application:

1. Information for staff assessment of possible reviewer conflicts

Include
for all Key Personnel and Other Significant Contributors a biographical sketch
with the educational block at the top of the format page completed and Section
B, Positions and Honors completed. List the principal investigator/program
director first and then other personnel biosketches in alphabetical order. Do
not include Sections A (Personal Statement), C (Selected peer-reviewed
publications or manuscripts in press), or D (Research Support) in this part of
the application. (See 2. below for where to place this information.) However,
do include reference to the part(s) of the application and page numbers where
complete biographical sketches for each individual are located.

To aid in
the review of the application, also insert a completed Table II:
“Distribution of Professional Effort on this Application” using the recommended format on the
NIA website.

2. Information
for reviewer assessment of personnel qualifications for roles on project.

Following
the instructions in the most recent PHS 398 form, complete full Biographical
Sketches for Key Personnel and Other Significant Contributors in the part(s) of
the application (Cores) where each individual contributes. When someone has a
role in more than one part of the application then a complete biosketch for
that person should be placed in each section where the individual has a role.
As the particular qualifications for roles may differ among Cores, the selected
publications and the description of qualifications for the individual may
differ among the multiple Biographical Sketches as needed.

F. Resources. Applicants should complete separate Resources pages for
all Cores. Reviewers will use information from the Resources page of the
Leadership and Administrative Core (LAC) to evaluate the quality of the overall
environment for the proposed OAIC.

Provide an
overview of major changes in the application. If Cores have been deleted or
added indicate that here and explain the changes under Significance (below).

B. Specific Aims (1 page). Describe the goals to be achieved by the OAIC, including:

The OAIC's selected area(s) of focus, and basis for selection

Crucial problems or limitations in knowledge, technology,
infrastructure, and/or availability of researchers that the OAIC would
address in the area(s) selected

Advances in regard to these problems or limitations in knowledge,
technology, infrastructure, and/or availability of researchers that the
OAIC would achieve over its five-year award period.

C. Research Strategy

Note: Items 1, 2, and 3 are limited to 6 pages in total.

1. Significance. Focusing on the OAIC as a whole, address (i) the
importance of the problem or critical barrier to progress in the field that the
proposed OAIC addresses, (ii) how the proposed OAIC will improve scientific
knowledge, technical capability, and/or clinical practice in one or more broad
fields, (iii) how the concepts methods, technologies, treatments, services, or
preventive interventions that drive this field will be changed if the proposed
aims are achieved. For renewals or resubmissions, include the following
additional information:

Renewals: Identify and justify any changes in
research emphasis and level of funds requested. If the structure of Cores has
changed, identify the Cores consecutively according to how they are arranged in
the current application. Show the correspondence to the prior structure.

Resubmissions: Follow PHS 398 instructions to
mark changes in the text from the prior version. If the structure of Cores has
changed, identify the Cores consecutively according to how they are arranged in
the current application. Show the correspondence to the prior structure.

2. Innovation. Considering the OAIC as a whole, show how the proposed
OAIC seeks to shift current research or clinical practice paradigms through use
of novel concepts, approaches, methodologies, instrumentation, or
interventions. Are these concepts, approaches, methodologies, instrumentation,
or interventions novel to the research field or novel in a broad sense? Does
the proposed work refine, or improve, or apply in a new way, the concepts,
approaches, methodologies, instrumentation, or interventions proposed?

3. Approach. Present the OAIC's overall strategy for serving as a sustained resource to the
research program in its selected area(s). Describe how it will accomplish the
innovation, intellectual leadership, translational, interdisciplinary,
collaborative, and career development functions expected of an OAIC. Describe
the specific activities that the OAIC will undertake to accomplish the goals
and strategy described above, including how the different components of the
OAIC will interact to help accomplish them, how the approaches of the Cores
complement each other or are inter-dependent, the mechanisms to ensure
coherence of the Center and maintainenance of an interdisciplinary focus, and
the mechanisms to be used in assessing progress toward the OAIC's goals.
Where appropriate, provide timelines and organizational charts. Note the
major OAIC Cores and other activities, referencing appropriate subsequent
sections of this application that contain more detail.

For renewals, describe findings (with citations) from the
prior period of support that are of particular significance to the OAIC as a
whole. If Cores included in the prior period of support are not part of the
current submission, describe their progress and explain why they are not
included. Identify and justify any substantive differences in approaches from
the prior period of support.

Additional Information. Discuss the
interrelationship of the OAIC to other activities in the applicant's
institution (e.g., other relevant research projects) and the extent of
institutional, departmental, and interdepartmental cooperation (a chart or
diagram to demonstrate the relationship may be used). In addition, describe the administrative relationships of the proposed
OAIC to the institution. Include relevant issues relating to institutional
commitment and settings. Renewal applications from existing OAIC sites may
use this section to present summary tables of OAIC activities (such as
those prepared for the mid-cycle review). Do not use this section to
discuss or expand on information that belongs elsewhere in the
application.

D. Other Elements

Follow PHS 398 instructions (section 5.5), in addition to
any further instructions below, to describe the following additional elements
of the OAIC as a whole:

Inclusion Enrollment Report (Renewal applications only)

Bibliography and References Cited / Progress Report Publication
List.

Protection of Human Subjects. Describe
fully the general principles and policies that will apply to human
subjects for the OAIC as a whole. List all components of the
application that involve human subjects and page numbers for the relevant
human subjects sections. Include in the appendix all consent forms for
human subjects research which apply to developmental projects or
pilot/exploratory studies.

Inclusion of Women and Minorities. Describe general principles and policies pertaining to inclusion of
women and minority study subjects in the OAIC as a whole.

Inclusion of Children.

Vertebrate Animals. Approval
must be by each individual protocol for projects not having approval
elsewhere. List the components in the application that involve vertebrate
animals and page numbers for the relevant vertebrate animal sections.

Select Agent Research.

Consortium/Contractual Arrangements. Before submitting an application that contains a consortium
arrangement, the applicant institution and each collaborating institution
should reach agreement on the scientific, administrative, financial, and
reporting requirements for the grant. Include the
following statement, accompanied by signatures of the appropriate
administrative officials, from each of the collaborating institutions:
"The appropriate programmatic and administrative personnel of each
institution involved in this grant application are aware of the NIH
consortium grant policy and are prepared to establish the necessary
inter-institutional agreement(s) consistent with that policy."
Include this information here and/or with individual Cores, as appropriate.

Letters of Support. Place
Institutional letters of support for the OAIC in this section.

Table III: Percentage Distribution of Resource Cores to OAIC-
and Externally Funded Research Projects. Use the recommended format for this
information on the NIA website.

All Personnel Report (Renewal
applications only).

III. OAIC Core Structure

To accomplish the program goals, each OAIC award will provide
support for the following components and activities:

1) A Leadership and Administrative Core (LAC) (required)
2) A Research Career Development Core (RCDC) (required)
3) One or more Resource Cores (RCs) (required)
4) A Pilot/Exploratory Studies Core (PESC) (optional)

5) An Information Dissemination Core (optional)

The Leadership and Administrative Core (LAC) will support
research planning and evaluation activities for the Cores, the OAIC as a whole,
and other administrative activities.

The Research Career Development Core (RCDC) will support career
development activities and infrastructure, including salary, fringe benefits,
travel, and didactic training for junior faculty who are conducting pilot
studies, developmental projects or working on independently funded projects.

An OAIC may provide support to a variety of types of research in its
area(s) of focus: a) testing of prevention, intervention, diagnostic, or
functional assessment techniques; b) translational research (including
mechanistic studies), experimental therapeutic studies in laboratory animals,
studies in animal models, and c) technology or methods development research.

Resource Cores (RCs) will
provide resources to (a) enhance or support projects funded primarily by other
mechanisms, and (b) develop and validate model systems (e.g., animal models),
methods, assays, analytic techniques, and equipment, as well as diagnostic,
assessment and survey instruments to advance aging research.

A Pilot/Exploratory Studies Core (PESC) is optional. The
PESCsupports pilot or exploratory research to acquire information
needed to select or design future crucial studies in the OAIC area of focus.

Each OAIC must support a significant amount of clinical research with
human subjects; however, every core within an OAIC is not required to support
studies on human subjects. Core support may be provided for basic and
translational research in animal models and in vitro systems and for
secondary data set analyses.

While most of the research supported by RCs, the PESC and the RCDC
should relate to the areas selected as the OAIC research theme(s), a limited
amount of support in these Cores is acceptable for topics in other areas of
aging research related to the goals of the NIA OAIC program, as noted above.

An Information Dissemination Core (IDC) is optional. OAICs may
request support for a core to disseminate information relating to their
research areas and/or to enhance translation of clinical research findings into
health care practice.

A. LEADERSHIP AND ADMINISTRATIVE CORE (LAC)

The Leadership and Administrative Core (LAC) will provide support for
planning, organizational, evaluation, and administrative activities relating to
the other Cores and to the OAIC as a whole. The Principal Investigator for the
OAIC application should be the Core Leader for the LAC. He/she should have
sufficient expertise in the OAIC's area of research focus to exercise effective
scientific judgment and leadership.

The LAC is responsible for monitoring, stimulating, sustaining,
evaluating, and reporting progress toward the overall goals of the OAIC.
Specifically, the LAC should conduct or organize the following activities:

Regular review of utilization of core resources by
the other OAIC cores, and reallocation of resources within or among cores.

Assessment of scientific opportunities for new
utilization of core resources, and planning to utilize them. One topic
that should routinely be assessed is the potential for translation between
basic and clinical research, e.g., research to develop or test
interventions or diagnostic tests based on new findings from basic aging
research or other basic research, or studies to improve understanding of
the mechanisms contributing to clinical or functional findings.

Assessment of potential areas for collaboration
among OAIC cores within the center, and with other OAICs or other
projects; and planning for collaborative activities, if merited.

Review of proposed Developmental Projects and
Pilot/Exploratory Studies by an independent panel or panels (see Resource
Core(s)) and review of salary support for junior faculty supported through
the Research Career Development Core.

The LAC may elect to convene a single panel or separate panels to
conduct reviews of the above activities. Panels may meet in person or by
teleconference. At least one third of the members of each panel should be
external to the awardee institution. Ad hoc reviewers may be invited to
participate in the panels to address specific projects in their areas of
expertise.

Additionally, active involvement of the LAC is required in the following
activities:

Yearly review of progress toward the OAIC goals by
an Advisory Board external to the awardee institution. Members of the
External Advisory Board (EAB) are selected by the OAIC subject to approval
by NIA. The names of potential advisory board members should
not be included in the application and potential members should not be
contacted until after the award; however, the operating procedures
of the EAB, including the frequency of its meetings and the methods
for the identification of members should be specified. A
report of the annual review by this Board should be included in annual
Progress Reports.

Preparation of information for a progress review by
an advisory panel selected and convened by NIA, at or shortly following
the conclusion of the second year of the OAIC award. This Mid-Cycle Review
will evaluate individual OAICs that have reached the midpoint of their
funding periods and advise NIA on the progress and direction of the OAIC
Program in general.

Preparation of administrative documents relating to
the award.

Additional activities for which the LAC may provide support include:

Research planning meetings (including participants
from other institutions) and support for invited scientific presentations.

Travel expenses for OAIC staff to visit other OAICs
for collaborative projects.

Participation of OAIC investigators and Coordinating Unit leadership at
an annual scientific meeting is mandatory. Participants will include the PD/PI,
Center Administrator, Core Leaders and others, as appropriate for purposes of
programmatic coordination and scientific exchange. Applications must include
budget requests for attendance at these meetings as part of the budget for the
LAC.

Up to $150,000 in first year direct costs may be requested for LAC
activities.

B. RESEARCH CAREER DEVELOPMENT CORE (RCDC)

A Research Career Development Core (RCDC) is a required component of an
OAIC. The RCDC should be led by a scientist with experience in research
training and a history of successful mentoring. The RCDC Core Leader will be
responsible for coordination, oversight, and reporting of the activities
described below.

The goal for the RCDC is to promote the development of future research
leaders in the OAIC area of focus, particularly leaders who can integrate
clinical insights regarding health/disease and independence/disability in old
age with knowledge of advances in the basic sciences to improve clinical
interventions for maintaining health and independence.

Toward this goal, the RCDC will provide salary and other support for
junior faculty and research associates to acquire research skills in the area
of OAIC focus. Specifically, the Research Career Development Core will provide
support for salary, didactic training, travel, information resources, and
secretarial or technical support. Junior faculty and research associates who
receive RCDC support may also receive funding for pilot/exploratory studies
(see Pilot/Exploratory Studies Core below). Funds for salaries and other
expenses of the Core Leader and support staff may be requested.

The career development plans for at least some of the junior faculty and
research associates supported through the RCDC should provide for the
development of combined competence in basic and clinical research. This should
be accomplished either by enhancing the clinical research experience of basic
scientists, developing basic research skills and experience of clinical
investigators, or providing a combination of the two approaches. An emphasis on
development of skills for translating basic findings into clinical research,
and clinical findings into mechanistic studies, is encouraged. Regarding the
goal of developing researchers with combined expertise in clinical and basic
research (including aging research), OAIC applicants should consider the
previous training of the individual candidate in determining the nature and
extent of didactic training and research activities for which RCDC support is
requested.

At least some of the junior faculty and research associates selected for
support through the RCDC should hold a clinical doctoral degree. The
development of strong aging-related research capabilities in individuals with
clinical geriatrics competence, as evidenced by Board certification of
qualifications in geriatrics, is a particular program priority. (Such
individuals include both those whose sole fellowship training is in geriatrics,
as well as those who have received training in both geriatrics and another clinical
specialty.) Although the inclusion of such individuals among those receiving
RCDC support is not a requirement for OAICs, applicants are strongly encouraged
to explore possibilities for recruiting and including such persons, and to
coordinate their activities with clinical training programs to encourage the
development of individuals with both training in geriatrics and research
interests in the OAIC area of focus. OAIC career development support for
RCDC-supported junior faculty and research associates should be integrated with
other sources of career support that they may be receiving (e.g., NIH
"K-series" career development awards, fellowship, non-NIH career
awards) in concerted programs for career development.

OAIC applicants should provide a plan for their strategy of recruiting,
selecting, mentoring, and monitoring the progress of individuals who will
receive RCDC support over the proposed OAIC award period, and describe the
abilities they expect recipients of this support to acquire. This plan should
include provision for peer review of proposals for provision of RCDC salary
support to junior faculty. At least one third of these peer reviewers should be
from outside the awardee institution. Special attention should be paid to the
recruitment of minority candidates for career development activities. Attention
to issues of health disparities is highly valued by the program.

In addition, the OAIC proposal should identify the individuals selected
for at least the first year of RCDC support, describe what their activities
will be, and delineate the nature of institutional commitments to the
individuals' development. A description of mentors' research activities
(including a biographical sketch of each mentor) and their commitments in
training and supervising these individuals should also be provided. The OAIC
goals for the individual's career progression by the end of the OAIC award
period should be described. The description should explain how the proposed use
of OAIC funds (including funds for pilot/exploratory study funding if this is
also proposed for the individual) will contribute to OAIC program goals for
research career development in its selected area of research focus.

If any RCDC activities involve human intervention studies funded by the OAIC,
NIA staff should receive, prior to their initiation, a description of the study
and plans for data and safety monitoring and for notification of clinically
significant events to NIA staff. Such plans should be consistent with NIA
policy (see http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm). In addition, if an RCDC will support human
intervention studies in the future, applications should describe procedures for
developing data and safety monitoring plans and notification of NIA staff.

A maximum of $450,000 in first-year direct costs may be requested for
the Research Career Development Core.

C. RESOURCE CORES (RCs)

Each Resource Core (RC) should be based on a research field or function
that contributes to the OAIC area(s) of focus. These cores may be defined in
terms of a biomedical or biotechnology field (e.g., clinical trials,
endocrinology, geriatric assessment, bioengineering); a service function (e.g.,
subject recruitment and retention, pathology, genotyping); or a supply function
(e.g., animals). A minimum of one RC is required for an OAIC application.

Innovative organizational approaches are encouraged for each Resource
Core proposed. A Core Leader should be named, and plans for the scientific and
administrative functioning should be presented. The method for prioritizing
access to core resources requested by multiple projects should be described.
Salary and other expenses for the core leader and administrative staff may be
requested.

In designing RCs, the applicant is strongly encouraged to consider the
full range of disciplines, technologies, methodologies, services, and resources
that could be applied to the OAIC's selected area(s) of focus. However, there
is no requirement that an OAIC Resource Core include this full range. The
selection of areas for Resource Cores should be made on the basis of the
contribution of services and support to the overall goals of the OAIC. A clear
statement of how individual cores will enhance the scientific productivity of
the projects and assist the center investigators to realize the OAIC objectives
for its area of focus must be provided in each application. The evaluation of
the justification for proposed cores by peer reviewers will include
consideration of the scientific merit of the core.

Examples of possible RCs include but are not limited to:

Recruitment/screening/assessment/registry units for
subjects in clinical research protocols, including clinical trials.

Diagnostic and pathophysiologic units for studies of
mechanisms of treatment response and interactions with disease.

Basic science laboratories providing assays or other
measures of cellular, molecular, or biochemical factors for clinical or
basic studies.

Biostatistical/data management units.

Cost-effectiveness analysis units.

Units for the support of laboratory animals used in
aging research and the development of animal models of age-associated
diseases.

RCs may provide services for developmental studies that are part of the
RC infrastructure (see below) and for pilot/exploratory studies included in the
PESC (see below). RCs should also provide services to enhance and integrate the
scientific contributions of basic and/or clinical research projects relevant to
the OAIC focus, whose support is independent of the OAIC (e.g., research funded
through R01, P01, U01, non-NIH mechanisms). In general, RCs are expected to
interact with the studies they support, providing expertise in the design,
conduct, and analysis of results as well as technical services or products.
Hence, support for professional staff time for such interactions is encouraged
where appropriate. Research-related patient care costs are eligible for support
though the RCs, but routine patient care costs may not be requested.

There is no limit to the number of proposed Resource Cores; however,
applicants should consider the feasibility of supporting multiple RCs within
the allowable OAIC budget. An applicant may not propose a Resource Core unless
it will support at least two projects. Evaluation of the justification for
proposed cores by peer reviewers will include consideration of the scientific
merit of the research projects supported by the cores (if
they have not previously been reviewed and funded by NIH).. External Projects will be evaluated
on the basis of previous peer review and funding source. Developmental Projects
within each Resource Core will be evaluated for scientific merit as a part of
the OAIC application review process.

Developmental Projects (DPs)

In addition to the support of services to other projects, RCs may
directly conduct a limited amount of technology, resource and/or methods
development projects. These projects are referred to below as DPs. The goal of
these DPs is to establish new methods or technologies that will enrich the
resources of the Core or the services it provides. Developmental
studies which challenge existing paradigms or develop new methodologies or
technologies are highly valued.

Examples of activities in DPs are listed below. However, this list does
not describe the full range of supported activities, nor is it intended to
direct applicants towards these areas.

Development or preliminary testing of new data
acquisition methods or technologies, assays, materials, or instruments to
assess their feasibility and potential to provide important information,
relevant to the OAIC focus, that is not available or less feasibly
obtained with current methods. The range of approaches in which such
projects may be conducted includes genetic, molecular, biochemical,
engineering, imaging, clinical diagnostic, functional assessment,
bioinformatics, and survey methods.

Development and testing of new data analytic and
computational strategies to allow more informative results from studies in
the OAIC area of focus.

Preliminary evaluation of new animal models for
relevant age-related outcomes.

Developmental Projects supported by a RC must relate to the overall
goals of the OAIC. A proposed RC may request support of up to $75,000 (direct
costs) per year for developmental projects. Specific developmental projects to
be conducted by an RC using these funds may last from one to five years. The
first year of developmental activities using these funds should be described in
detail in the OAIC application, clearly delineating the approach taken for
developing and testing the new methods or analytic approaches and discussing
how the results will be analyzed. Developmental activities for subsequent years
must be reviewed by the OAIC internal and external review mechanisms (see LAC
section).

NIA requires that program staff be notified when a developmental grant
award is made by an OAIC to its investigators; however, this can be done at the
time of the progress report, unless the developmental grant involves a human
intervention study funded by the OAIC, in which case a description of the study
and plans for data and safety monitoring must be communicated to, and approved
by, NIA staff prior to initiation of the study. In addition, if the RC will
support developmental projects involving human intervention studies in the
future, the application should include a description of procedures for
developing data and safety monitoring plans and notification of NIA staff.

D. PILOT/EXPLORATORY STUDIES CORE (PESC)

Inclusion of a PESC is optional. OAICs may conduct Pilot/Exploratory Studies
(PESs) to acquire information needed to select or design future crucial studies
in the OAIC area of focus. PESs may be categorized as standard PESs or small
PESs based on their budgets (described below). These studies may be led by
junior faculty and or research associates receiving OAIC RCDC support,
or by other senior or junior investigators. A scientist responsible for
leadership of this Core must be identified in the OAIC application.

Funding for Pilot/Exploratory Studies (PESs) may be for:

Preliminary testing of an intervention or other
research protocol in humans or animals for safety, feasibility, or
determination of optimal time course or dosage

Analysis of data acquired in ongoing or previous
studies to explore hypotheses that may guide the selection and design of
future studies

The above examples are not exhaustive of the types of PESs that could be
supported.

A maximum of $250,000 in direct first-year costs may be requested for
the PESC to support PESs. Applicants may propose up to 5 PESs in the first year.
Direct costs should range between $25,000 and $50,000 per year for standard PESs,
and $10,000 or less for small PESs. All PESs may not exceed 3 years in
duration. Up to $50,000 of the $250,000 budget for the PESC may be devoted to
small PESs.

PESs for the first year of the proposal should be included in the OAIC
application. The specific aims of each proposed PES must address the
relationship of the PES to the overall theme or focus of the OAIC.
Specific aims and research strategy for each proposed PES should be included in
this Core. Budgets should be prepared for all 5 years of the OAIC application.

OAIC-supported pilot studies involving human interventions require
approval by NIA staff prior to their initiation. Investigators planning to
conduct pilot studies involving human interventions must communicate to NIA
staff a description of the study and plans for data and safety monitoring and
for notification of clinically significant events to NIA staff. Such plans
should be consistent with NIA policy (see http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm). Pilot studies that do not involve human
interventions do not require advance approval by NIA; however, NIA does require
that program staff be notified of such a pilot grant award having been made.
This can be done at the time of the progress report (see Section VI.3). In
addition, if the PESC will support human intervention studies in the future,
the application should include a description of procedures for developing data
and safety monitoring plans and notification of NIA staff.

Inclusion of
an IDC is optional. OAICs may request support for a core to disseminate
information relating to their research areas and/or to enhance translation of
clinical research findings into health care practice. These activities
may include communication with professional societies, and private and public
organizations responsible for health care of older persons or policies
affecting clinical research on older persons. Examples of possible activities
include, but are not limited to, preparation of information and
organization of briefings for key health care organizations,
collaborative activities for information exchange among multiple governmental
and nongovernmental organizations, and participation in the development of
evidence-based practice guidelines by professional societies. A maximum of
$60,000 direct costs per year may be requested for this Core. The types of
activities planned for the Core, the criteria and process for their selection,
and the staffing and organization of the Core and its relation to the Leadership
and Administrative Core should be presented.

IV. HOW
TO ORGANIZE INDIVIDUAL CORES

Prepare each
Core as a separate section that begins on a new page of the application.
Continue to number the pages consecutively. Include the Core leader’s
name at the upper right-hand corner of each page under the PI’s name.

Each
Resource Core (RC) should be numbered sequentially and identified by titles
(e.g., Recruitment Core, Biostatistics Core, etc.) and consecutive numbers
(RC1, RC2, etc.). Number External Projects and Developmental Projects (DPs)
associated with RCs sequentially as EP-1, EP-2, DP-1, DP-2, etc., regardless of
the Core to which they are attached.

Following is
information describing the organization of each individual Core section, with
more specific information particular to each Core, as needed.

F. Budget (PHS 398 Form Page 4 and Form Page
5). Provide budgets for the first 12-month budget
period and for the entire grant period for each Cores (including a detailed
budget justification). Future year annual increases are limited to no more than
3%. Detailed guidance specific to each Core follows:

LAC: Support for salary, travel,
and other expenses of the LAC Director, Administrator, and appropriate
administrative staff may be requested. Support for members of advisory
panels to the OAIC to individual Cores (e.g., RCDC, RC, and PESC) should
also be requested within the LAC budget. First year direct costs should
not exceed $150,000.

Special Requirement: Participation of
OAIC investigators at an annual OAIC scientific meeting attended by NIA
staff is mandatory. Participants will include the PD/PI, Center
Administrator, Core Leaders, and others, as appropriate for purposes of
programmatic coordination and scientific exchange. Applications
must include budget requests for attendance at these meetings as part of
the budget for the LAC.

RCDC: First year direct costs are limited to a maximum
of $450,000.

RCs: First year direct costs for each proposed RC are
limited to a maximum of $75,000. This includes $35,000 (minimum) to
$75,000 (maximum) in first year direct costs per Developmental Project. A
maximum of two Developmental Projects can be requested as part of each RC.
There is no limit to the number of proposed RCs; however, applicants
should consider the feasibility of supporting multiple RCs within the OAIC
budget limits.

PESC: First year direct costs for the PESC are limited
to a maximum of $250,000 to support standard and small Pilot/Exploratory
Studies (PESs). Up to 5 PESs may be proposed for the first year. Direct costs
should range between $25,000 and $50,000 per year for standard PESs, and
$10,000 or less for small PESs. PESs may not exceed 3 years in duration.
Up to $50,000 of the $250,000 budget for the PESC may be devoted to small PESs.
List the budget for all years of each proposed PES as a line item within
the overall PESC budget.

IDC: First year direct costs for the IDC should not
exceed $60,000.

G. Biographical Sketches. Provide a complete Biographical Sketch (PHS 398 parts A
– D) for each individual associated with the Core. The Core Leader is
considered the Program Director/Prinicpal Investigator of the Core. Biographical
Sketches are limited to 4 pages and no more than 15 peer-reviewed publications
or manuscripts in press.

For new OAIC applications, prospective advisory committee
members should not be named in the application or recruited until after the
review is complete (though criteria used to select advisors should be described
in the appropriate section of the application). For consultants who are currently
employed, or with whom prospective employment has already been discussed,
identify them by name and indicate their respective institutions.

Detailed guidance particular to the individual Cores
follows:

a. LAC: As the
Principal Investigator of the proposed OAIC should also be the Core Leader of
the LAC, his/her Biographical Sketch should present his/her scientific
expertise in the proposed OAIC's area(s) of focus and his/her capacity for the
leadership of a center of excellence in aging research. Consultants to the OAIC
as a whole should be listed in the LAC section; consultants specific to a
particular Core should be listed in the appropriate Core section.

b. RCDC: Present
all personnel involved in the RCDC, including Core Leader, Senior/Key
Personnel, potential Mentors, Consultants, other significant Contributors, and
all Career Development Candidates. The personal statement section of the
Biographical Sketch should outline the planned career development activities
for each Career Development Candidate. Mentors should describe their planned
activities in support of Career Development Candidates.

c. RC, PESC, and IDC: Present all personnel involved in the Core, including Core Leader,
Senior/Key Personnel, Consultants, and other significant Contributors. Descriptions
of the qualifications of each proposed Core Leader and other personnel
relevant to the functions of the Core should be included here.

H. Resources. Describe resources and environment that are relevant
and/or unique to the individual Core.Note: Reviewers will use
information from the Resources page of the LAC to evaluate the quality of the
overall environment for the proposed OAIC.

I. Introduction (1 page). For resubmission
applications ONLY. The Introduction should be a summary response
to the global concerns expressed about the proposed Core during the previous
review.

J. Specific Aims (1 page)

LAC: Provide an overview of
how the LAC particularly will implement the theme of the center.

RCDC: Describe what the
intended outcomes and career advancement goals are for RCDC scholars.

RC: Show the intended role
of the Resource Core in relation to the Center as a whole and to the theme of
the Center. Use this section to summarize the specific aims of each External
Project (EP) or Developmental Project (DP). If an EP is supported by more than
one OAIC RC, list the External Project in each RC and state the pages in the
application where the initial description can be found.

PESC: Outline the topic
areas to be solicited and the expected outcome for pilot or exploratory study
awards.

IDC: Describe the role of
the IDC in enhancing translation of clinical research findings into health care
practice.

K. Research Strategy (6 pages)

Organize the Research Strategy into sections on: a.
Significance; and b. Approach.

a. Significance

Up to 1 page is recommended for the Significance section
of each Core.

LAC: Describe
the overall role of the LAC in the OAIC.

RCDC: Describe
the contribution of the RCDC to the OAIC’s overall goals. Describe how
the Core Leader and other mentors will help implement the intended goals of the
RCDC.

RC: Explain
the intended strategy in developing this resource and how research quality and
efficiency would be enhanced by use of the services of the RC. Specify
pertinent uses of the RC by junior faculty and how such use will promote
research leading to increased independence of older persons. Describe how each
External or Developmental Project planned for support through this Core will
achieve the goal of the RC and the overall goals of the OAIC.

PESC: Describe
how Pilot/Exploratory studies (PES) will fit within the goals of the PESC and
how they will interact with other Core Resources of the OAIC.

IDC: Explain
the purpose and functions of the IDC. Present a clear statement of how the IDC
relates to the theme or focus of the OAIC and how it will contribute to the
goals of the OAIC.

b. Approach

In the guidance below, 5 pages are recommended for the
Approach section of each Core.

LAC: Describe
the administrative structure of the LAC, the administrative relationships between
the LAC and all other OAIC components, and the ways in which they will interact
to achieve the OAIC’s goals and maintain quality of the OAIC. Describe
the activities of the LAC leader (the PD/PI of the OAIC), the Center
Administrator, and other LAC staff in carrying out its functions. A crucial
component of this description is the activities of the LAC leader in
monitoring, stimulating, sustaining, evaluating, and reporting the OAIC’s
progress toward the overall goals of the OAIC. Present plans to establish and
operate OAIC advisory panels, including criteria for selecting advisors, how
they will be identified, the operating procedures of the panel, and the
frequency of meetings. Advisory panels include:

An External Advisory Board consisting of
experts from outside the OAIC and the grantee institution who meet yearly to
review its progress and provide a written report to the OAIC Director which is
to be included in the Center’s annual progress report to NIA; and

Other advisory panels to assist in selecting
junior faculty for salary support through the RCDC, for developmental projects
through the Resource Cores, and for Pilot/Exploratory Studies. At least
one-third of members of these panels should be external to the OAIC and the
grantee institution.

Note: New applications should not name potential
advisors in the application or select advisors prior to peer review of the OAIC
application.

RCDC: Describe
the plan for recruiting, selecting and advancing the progress of individuals
who will receive RCDC support. The plan should include use of an Advisory Panel
(the composition and functioning of which should be described in detail in the
LAC research strategy). Describe the kinds of educational activities planned
for the candidates. These might include regular research meetings, invited
guest faculty, workshops, formal courses, etc. In addition, brief descriptions
of the planned research and associated career development activities for up to
five junior faculty should be presented. Descriptions in this Approach section
should include the research plan proposed by each Candidate, how OAIC resources
(e.g., Pilot/Exploratory Study Core) will contribute to the research plan, and
the mentor(s) for the candidate. Planned career development activities for each
Candidate should be described in his/her Biographical Sketch. Mentors’
qualifications, commitment to training, and proposed support activities for
Career Development Candidates should be described in the Mentor’s
Biographical Sketch. The Institutional commitment to the Career Development
Candidates should be described in the Resources section of the RCDC
application. For renewal applications, include information on the progress of
the RCDC during the previous funding period.

RC: Describe
the operations of the Core. Present a detailed plan for how External and
Developmental Projects eligible for Core support will be reviewed, selected,
and prioritized for access to Core resources for all years of the grant period.
Describe how the Core leader, together with the OAIC PD/PI, will monitor and
evaluate ongoing progress of EPs and DPs in the context of RC support. This
plan should include the use of an advisory committee (the composition and
functioning of which should be described in detail in the LAC research strategy.)
In addition, present information about External Projects (EPs) and
Developmental Projects (DPs) as follows:

External Projects (EPs). For each EP proposed for Core support during the first
year of the OAIC grant, list the PD/PI, title of award, source of award, and
duration of external support. In addition, briefly present the approach and any
innovative aspects of each EP that has not been presented elsewhere, or
otherwise, the pages in the application where the initial description can be
found.

Developmental Projects (DPs). Each RC may support a maximum of 2 DPs, each lasting 1-5
years, to explore new technologies, resources, and/or methodologies for
application by the RC. For each DP, list the Title, Project Leader and
Senior/Key Personnel (including page references to their Biographical
Sketches), a description of the approach that the DP will use to achieve its
goals, and any innovative aspects. Also describe how DPs will interact with other
Core resources of the OAIC.

PESC. Describe
the operation of the PESC and the types of applications that will be supported
(e.g., will small PESs be allowed?). Provide a detailed plan for how PESs will
be solicited, peer-reviewed, selected, prioritized for access to Core
resources, and overseen. This plan should include the use of an Advisory Panel
(the composition and functioning of which should be described in detail in the
LAC research strategy). Describe how the Core Leader, together with the OAIC
PD/PI, will monitor ongoing progress of studies and assist in the planning for
the development of PESs into independently funded grant applications, where
appropriate. In addition to the operations of the PESC, present individual
Pilot/Exploratory Studies (PESs) as follows:

Pilot/Exploratory Studies (PESs). Up to 5 PESs may be supported for the first year. Number
each PES sequentially (e.g., PES-1, PES-2, etc.). For each PES, list the Title,
Project Leader and Senior/Key Personnel (including page references to their
Biographical Sketches), and a description of the approach that the PES will use
to achieve its goals. Describe any innovative aspectives of the PES. Describe
how the PES will interact with other Core resources of the OAIC.

IDC. Describe
the operation of the IDC. Describe the types of activities that the IDC will
conduct to disseminate information relating to the OAIC’s research areas.
Describe the organizations and/or institutions that will interact with the
proposed IDC. Provide a plan describing how the proposed activities of the IDC
will be evaluated. Describe how the IDC will interact with other Core
resources of the OAIC.

L. Other Elements

Follow PHS
398 instructions (section 5.5), in addition to any further instructions below,
to describe the following additional elements specific to each Core or study
within the Core:

Inclusion Enrollment Report (Renewal applications only)

Bibliography and References Cited / Progress Report Publication
List.

Protection of Human Subjects. Describe
fully the general principles and policies that will apply to human subjects
for the OAIC as a whole. List all components of the application that
involve human subjects and page numbers for the relevant human subjects
sections. If the application describes specific human intervention
studies, then, for each study, describe the plan for data and safety
monitoring and notification of NIA staff as consistent with NIA policy (http://www.nia.nih.gov/GrantsAndTraining/Policies/ImplementationPolicies.htm). In addition, if a Core will support human intervention studies
currently or in the future, describe procedures for developing data and
safety monitoring plans and notification of NIA staff. Include in the
appendix all consent forms for human subjects research which apply to
developmental projects or pilot/exploratory studies.

Inclusion of Women and Minorities. Describe general principles and policies pertaining to inclusion of
women and minority study subjects in the OAIC as a whole.

Inclusion of Children.

Vertebrate Animals. Approval
must be by each individual protocol for projects not having approval
elsewhere. List the components in the application that involve vertebrate
animals and page numbers for the relevant vertebrate animal sections.

Select Agent Research.

Consortium/Contractual Arrangements. Before submitting an application that contains a consortium
arrangement, the applicant institution and each collaborating institution
should reach agreement on the scientific, administrative, financial, and
reporting requirements for the grant. Include the following statement, accompanied by signatures of the
appropriate administrative officials, from each of the collaborating
institutions: "The appropriate programmatic and administrative
personnel of each institution involved in this grant application are aware
of the NIH consortium grant policy and are prepared to establish the
necessary inter-institutional agreement(s) consistent with that
policy." Include this information here and/or in the “Summary
of the OAIC” as appropriate.

Letters of Support. Include letters
from Senior/Key Personnel, Consultants, and Other Significant Contributors
(1 page maximum).

RESUBMISSION

Applicants
who responded to OAIC RFAs AG-07-008 and AG-10-003 but did not receive awards
may submit resubmission applications in response to this FOA. One
introduction page is allowed at the beginning of Section II (Summary of the
OAIC) to outline the response to reviewers’ concerns, and one additional
page is allowed in each Core section to address concerns relevant to that Core.

All appendix
materials should be contained within one PDF file no larger than 20 megabytes.
The file should be organized into folders in the order of the Cores to which
the information relates. Refer to the PHS 398 instructions for guidance on
which materials are allowable in the Appendix.

Do not use
the Appendix to circumvent the page limitations. An application that does
not observe the required page limitations may be delayed in the review process.

Resource Sharing
Plan(s)

NIH considers the sharing of unique research
resources developed through NIH-sponsored research an important means to
enhance the value of, and advance research. When resources have been developed
with NIH funds and the associated research findings published or provided to
NIH, it is important that they be made readily available for research purposes
to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this should be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide
NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section
V. Application Review Information

1. Criteria

Only the review
criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications
that are complete and responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the National Institute on Aging and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer
review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned an impact/priority
score.

Receive
a written critique.

Receive
a second level of review by the National Advisory Council on
Aging.

The mission
of the NIH is to support science in pursuit of knowledge about the biology and
behavior of living systems and to apply that knowledge to extend healthy life
and reduce the burdens of illness and disability. As part of this
mission, applications submitted to the NIH for grants or cooperative agreements
to support biomedical and behavioral research are evaluated for scientific and
technical merit through the NIH peer review system.

Overall Impact of the Proposed OAIC

Reviewers
will provide an overall impact/priority score to reflect their assessment of
the likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved, in consideration of the following five scored
review criteria, and additional review criteria (as applicable for the project
proposed).

Scored Review Criteria

Reviewers
will consider each of the five review criteria below in the determination of
scientific and technical merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature
is not innovative may be essential to advance a field.

The
proposed OAIC will be reviewed both as a whole and by each Core for each of the
criteria below. For the OAIC as a whole, reviewers will give numerical impact
ratings, but for each Core, reviewers will provide only adjectival descriptors.

OAIC
AS A WHOLE

Significance. Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change
the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

The
following questions are also considered in evaluating the overall significance
of the proposed OAIC:

How
important are the OAIC's selected area(s) of focus in regard to potential
advances in understanding or treating age-related conditions affecting
independence of older Americans?

Will
the goals set for the OAIC over the project period significantly
contribute to advances in its area(s) of focus?

Will
the OAIC have a significant effect on the concepts or methods that drive
efforts to enhance independence for older persons?

To
what extent will the center cores facilitate other ongoing research to
advance aging and geriatric research?

Investigator(s).
Are the PD/PIs, collaborators, and other researchers well suited to the
project? If Early Stage Investigators or New Investigators, or in the
early stages of independent careers, do they have appropriate experience and
training? If established, have they demonstrated an ongoing record of
accomplishments that have advanced their field(s)? If the project is
collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

The
following questions are also considered in evaluating the investigators of the
overall proposed OAIC:

Is
the proposed leadership adequate for achieving the goals of the OAIC? Are
the OAIC PD/PI and lead investigators appropriately trained and well
suited to the organizational and scientific responsibilities associated
with this project? Is the PI an established investigator in a major area
selected as a focus of OAIC research?

To
what extent does the PI have the leadership qualities, including the
ability to work collaboratively with other investigators, to establish
mechanisms for quality control of the science receiving core funds, and to
move the OAIC into new innovative research areas as appropriate?

Does
the PD/PI demonstrate the ability for the translation of new scientific
findings in basic aging research into testing of interventions in animals
and humans?

If
there are plans to recruit investigator(s), are those plans reasonable and
necessary and can those efforts be completed in a timely manner, such that the
recruited investigator(s) can make meaningful contributions to the OAIC?

Innovation. Does
the application challenge and seek to shift current research or clinical
practice paradigms by utilizing novel theoretical concepts, approaches or
methodologies, instrumentation, or interventions? Are the concepts,
approaches or methodologies, instrumentation, or interventions novel to one
field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

The
following questions are also considered in evaluating the overall innovation of
the proposed OAIC:

How
effectively will the OAIC facilitate and develop novel multidisciplinary
and interdisciplinary research strategies?

Does
the OAIC group challenge existing paradigms or develop new methodologies
or technologies?

To
what extent will the OAIC stimulate translation between basic and clinical
research?

To
what degree will the OAIC add new research directions that are based on
insights from basic aging research or geriatrics?

Approach.
Are the overall strategy, methodology, and analyses well-reasoned and
appropriate to accomplish the specific aims of the project? Are potential
problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

The
following questions are also considered in evaluating the overall approach of
the proposed OAIC:

Has
one or more important topics been selected as an area of research focus? Is
the proposed strategy adequate for promoting a sustained research program
in the selected area(s) of focus through which the OAIC will accomplish
the innovation, leadership, collaborative, and career development
functions sought? Are the goals to be achieved within the five-year OAIC
award period specified? Is the plan to reach these goals, and the proposed
methods to evaluate progress toward these goals adequate during the course
of the OAIC award?

Are
the plans for monitoring, stimulating, sustaining, evaluating, and
reporting progress toward the overall goals of the OAIC adequate? Are they
clearly stated and are approaches specified to deal with inadequate
progress toward achieving goals, should this occur?

Are
the plans for the external review of the overall OAIC adequate?

Are
the arrangements adequate for internal quality control of ongoing
research, the allocation of funds, day-to-day management, contractual
agreements, the internal communication and cooperation among investigators
in the program?

How
effectively does the program incorporate both fundamental discovery and
the development of applied research?

How
clear is the plan for defining sharing of responsibilities among
investigators and between institutions (if more than one institution is
involved)? If collaborative arrangements are proposed, is there a
convincing demonstration that these interactions will be consistent enough
to meet the needs of the OAIC?

How
thoughtfully does the applicant acknowledge potential problem areas and
consider alternative approaches?

Environment. Will the
scientific environment in which the work will be done contribute to the
probability of success? Are the institutional support, equipment and
other physical resources available to the investigators adequate for the
project proposed? Will the project benefit from unique features of the
scientific environment, subject populations, or collaborative arrangements?

The
following questions are also considered in evaluating the overall environment
of the proposed OAIC:

To
what extent is there evidence of significant commitment of the institution
to fulfilling the objectives of the OAIC?

What
is the quality of the academic and physical environment as it bears on
patients, space, and equipment and on the potential for interaction among
scientists within the center and with scientists from other departments,
institutions, and OAICs? Will the OAIC serve as a source of advice in the
area(s) of its theme(s) regarding technology, methodology, analysis, or
other expertise?

To
what extent will the OAIC interact with other Institutional-, NIA-, and
NIH-supported resources, including Centers and large collaborative
projects, particularly in sharing resources (e.g., Research Cores) and
training opportunities.

CORES

Each
Core will be evaluated according to the following criteria:

Significance

Does the project address
an important problem or a critical barrier to progress in the field? If
the aims of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful
completion of the aims change the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field?

The
following questions are also considered in evaluating the significance of each
Core:

LAC:
How will the LAC contribute to achieving the overall goals of the proposed
OAIC?

RCDC:
How effectively will the OAIC promote the development of future research
leaders in its area(s) of focus, particularly leaders who can integrate
clinical insights regarding health, disease, independence, and disability
in old age with knowledge of advances in the basic sciences, including
gerontology, to develop better interventions to maintain health and
independence?

RCs:
How do the aims of the RC fit with the goals and theme(s) of the proposed
OAIC? How will the quality and efficiency of the proposed OAIC be enhanced
through the RC? How will the RC contribute to the success of other Cores?
How will the External and Developmental Projects contribute to the aims of
the RC and to the overall goals of the proposed OAIC?

PESC:
How will the proposed PESs and types of future PESs contribute to the
goals of the OAIC? How will the PESs contribute to the success of other
Cores?

IDC:
How will the IDC contribute to the overall goals and theme(s) of the
proposed OAIC? How will the IDC enhance the function of other Cores?

Investigators

Are the PD/PIs,
collaborators, and other researchers well suited to the project? If Early
Stage Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If
established, have they demonstrated an ongoing record of accomplishments that
have advanced their field(s)? If the project is collaborative or
multi-PD/PI, do the investigators have complementary and integrated expertise;
are their leadership approach, governance and organizational structure
appropriate for the project?

The
following questions are also considered in evaluating the investigators of each
Core:

LAC:
Are the leadership and administrative staff of the LAC in leading the
operations of the proposed OAIC qualified?

RCDC:
To what extent do the proposed Career Development Candidates demonstrate
commitment to, and potential for success in, a career in aging research?
Is there evidence of adequate numbers of outstanding junior investigators
with interest and commitment to aging research?

RC:
Are the personnel qualified to achieve the proposed aims of the RC? Are
the investigators qualified in achieving the proposed aims of their
External or Developmental Projects?

PESC:
Are the personnel qualified in achieving the goals of the PESC? Are the
investigators qualified in performing the proposed PESs?

IDC:
Are the personnel qualified in achieving the proposed aims of the IDC?

Approach

Are the overall strategy,
methodology, and analyses well-reasoned and appropriate to accomplish the
specific aims of the project? Are potential problems, alternative
strategies, and benchmarks for success presented? If the project is
in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

The
following questions are also considered in evaluating the approach of each
Core:

LAC:
How well will the proposed LAC staff lead the proposed OAIC and interact
with other OAIC components and other organizational components within and
outside the institution? Are the plans adequate for the establishment and
functioning of the proposed advisory panels?

RCDC:
Does the RCDC provide adequate educational and other career development
opportunities for fellows, junior faculty and other professional and
paraprofessional personnel associated with the Center? How well does the
RCDC provide training of young investigators in clinical translational
research? The quality of the plans to promote linkages between mechanistic
and applied research are an important aspect in the evaluation of the
RCDC.

RCs:
Does the RC enhance the quality of research, career development, and pilot
projects? Is the plan adequate for prioritizing access to RC resources? Are
the plans adequate for the external review of the proposed developmental
projects?

PESC:
What is the scientific quality of the pilot/exploratory studies proposed
and are they likely to acquire information needed to select or design
future crucial studies in the OAIC area(s) of focus? Are the plans adequate
for the external review of the proposed PESs? To what extent will the PESC
support translational PESs?

IDC:
What is the quality of the proposed activities of the IDC? How successful
are the proposed activities likely to be in achieving the goals of the
IDC?

Environment

Will the scientific
environment in which the work will be done contribute to the probability of
success? Are the institutional support, equipment and other physical
resources available to the investigators adequate for the project
proposed? Will the project benefit from unique features of the scientific
environment, subject populations, or collaborative arrangements?

The
following questions are also considered in evaluating the environment of the
Core:

LAC:
Will the resources and environment of the LAC adequately contribute to the
leadership of the proposed OAIC and to achieving its goals?

RCDC:
To what extent will the resources and environment of the RCDC lead to
selection of high quality Career Development Candidates? To what extent
will RCDC resources contribute to the successful development of junior
faculty?

RC:
Are the resources and environment of the RC adequate to achieve its aims
and the goals of the proposed OAIC? How will the

PESC:
To what extent will the resources and environment of the PESC contribute
to the quality and success of PESs?

IDC:
Are the resources of the IDC adequate to achieve its proposed aims?
To what extent will the IDC be able to access and interact with other
institutional resources for its proposed activities? To what extent will
existing relationships between the institution and other organizations or
societies, as well as those to be developed, contribute to the success of
the IDC’s goals?

Additional Review Criteria

As applicable
for the project proposed, reviewers will consider the following additional
items in the determination of scientific and technical merit, but will not give
separate scores for these items.

Protections
for Human Subjects. For research that
involves human subjects but does not involve one of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate the
justification for involvement of human subjects and the proposed protections
from research risk relating to their participation according to the following
five review criteria: 1) risk to subjects, 2) adequacy of protection against
risks, 3) potential benefits to the subjects and others, 4) importance of the
knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research
that involves human subjects and meets the criteria for one or more of
the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials.

Inclusion
of Women, Minorities, and Children. When
the proposed project involves clinical research, the committee will evaluate
the proposed plans for inclusion of minorities and members of both genders, as
well as the inclusion of children.

Vertebrate
Animals. The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following five points: 1) proposed use of the animals, and
species, strains, ages, sex, and numbers to be used; 2) justifications for the
use of animals and for the appropriateness of the species and numbers proposed;
3) adequacy of veterinary care; 4) procedures for limiting discomfort,
distress, pain and injury to that which is unavoidable in the conduct of
scientifically sound research including the use of analgesic, anesthetic, and
tranquilizing drugs and/or comfortable restraining devices; and 5) methods of
euthanasia and reason for selection if not consistent with the AVMA Guidelines
on Euthanasia.For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards. Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmission Applications. When reviewing a Resubmission application (formerly
called an amended application), the committee will evaluate the application as
now presented, taking into consideration the responses to comments from the
previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly
called a competing continuation application), the committee will consider the
progress made in the last funding period.

For
renewal applications from existing OAICs, the following questions are also
considered:

Does
progress over the previous award period support the continuation of this
OAIC?

To
what extent do the activities proposed for the competitive continuation
build on the research results supported by the previous award to advance
aging research its area of focus?

If
the area(s) of focus in the renewal application has (have) changed from
that in the previous award, to what extent does this new direction (a)
build upon the scientific accomplishments of the previous award; (b)
integrate the infrastructure of the existing OAIC; and (c) meet the review
criteria for Significance listed above?

Revision
Applications. . Revisions are not allowed for
this FOA.

Additional
Review Considerations

As applicable
for the project proposed, reviewers will address each of the following items,
but will not give scores for these items and should not consider them in
providing an overall impact/priority score.

Applications
from Foreign Organizations. Foreign
are not allowed for this FOA.

Select
Agents Research. Reviewers will assess the information provided
in this section of the application, including 1) the Select Agent(s) to be used
in the proposed research, 2) the registration status of all entities where
Select Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

A
formal notification in the form of a Notice of Award (NoA) will be
provided to the applicant organization. The NoA signed by the grants management
officer is the authorizing document. Once all administrative and programmatic
issues have been resolved, the NoA will be generated via email notification
from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished when a recipient changes institutions or
when an award is terminated.

Section
VII. Agency Contacts

We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule.

Policy
for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088. For additional information,
see http://grants.nih.gov/grants/gwas/

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this
funding opportunity in a public archive, which can provide protections for the
data and manage the distribution for an indefinite period of time. If so, the
application should include a description of the archiving plan in the study
design and include information about this in the budget justification section
of the application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of
grantees and contractors to elect and retain title to subject inventions
developed with Federal funding pursuant to the Bayh Dole Act (see the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or
contract proposal, beginning with the October 1, 2004 receipt date, are
expected to include in the application/proposal a description of a specific
plan for sharing and distributing unique model organism research resources
generated using NIH funding or state why such sharing is restricted or not
possible. This will permit other researchers to benefit from the resources
developed with public funding. The inclusion of a model organism sharing plan
is not subject to a cost threshold in any year and is expected to be included
in all applications where the development of model organisms is anticipated.

Inclusion of Women
And Minorities in Clinical Research:It is the policy of the
NIH that women and members of minority groups and their sub-populations must be
included in all NIH-supported clinical research projects unless a clear and
compelling justification is provided indicating that inclusion is inappropriate
with respect to the health of the subjects or the purpose of the research. This
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). All investigators proposing clinical research should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the
updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy
incorporates: the use of an NIH definition of clinical research; updated racial
and ethnic categories in compliance with the new OMB standards; clarification
of language governing NIH-defined Phase III clinical trials consistent with the
new PHS Form 398; and updated roles and responsibilities of NIH staff and the
extramural community. The policy continues to require for all NIH-defined Phase
III clinical trials that: a) all applications or proposals and/or protocols
must provide a description of plans to conduct analyses, as appropriate, to
address differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual and
progress in conducting analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.

Required Education
on the Protection of Human Subject Participants:NIH policy requires
education on the protection of human subject participants for all investigators
submitting NIH applications for research involving human subjects and
individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

NIH Public Access Policy Requirement:In accordance with
the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must
submit or have submitted for them their final, peer-reviewed manuscripts that
arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008, investigators
must include the PubMed Central reference number when citing an article in NIH
applications, proposals, and progress reports that fall under the policy, and
was authored or co-authored by the investigator or arose from the
investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS) issued
final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/) provides information on the
Privacy Rule, including a complete Regulation Text and a set of decision tools
on "Am I a covered entity?" Information on the impact of the HIPAA
Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH
Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy
People 2010:The Public
Health Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.

Authority and
Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372. Awards are made under the authorization of Sections 301 and 405 of
the Public Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan
Repayment Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further information,
please see: http://www.lrp.nih.gov.